CN105578993A - Surgical heart valves identifiable post-implant - Google Patents

Abstract

A prosthetic heart valve configured to replace a native heart valve and for post- implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post- implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in- valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

Description

Discernible Surgical heart valve after the implantation

Technical field

The disclosure relates to the Surgical heart valve for cardiac valve replacement, and relates more specifically to the Surgical heart valve with indicator, and this indicator can after the implantation from external.

Background technology

Heart is for having four pumping chambeies and four valvular hollow muscular organ, and four cardiac valve are: aortic valve, Bicuspid valve (or two cusp), Tricuspid valve and valve of pulmonary trunk.Cardiac valve is by being called as the feltwork ring of lobe ring and being attached to the lobule of lobe ring or tip (cusp) forms.

Valvular heart disease is the common situation that one or more valves of heart can not normally run.Ill cardiac valve can be divided into narrow and/or functional defect, in narrow situation, valve is not fully opened to allow blood by the suitable flow forward of valve, in functional defect situation, valve is not exclusively closed, and to cause when valve closes blood by valve excessive backward flow.Valve disease can make health seriously weak, and if do not treat, and even can be fatal.Various surgical technic can be used to displacement or repair diseased valve or damaged valve.In traditional valve replacement surgery, impaired lobule is usually cut, and lobe ring by moulding with receive displacement artificial valve.

Surgery Cardiac valve prosthesis generally includes supporting construction (such as, framework, ring and/or support), and supporting construction has the valve assemblies of disposing wherein.Supporting construction is generally rigidity, and can be made up of various biocompatible materials, comprises metal, plastics, pottery etc.The cardiac valve replacement of known two kinds of main Types or prosthese.One type is mechanical type cardiac valve, it uses the ball cage layout or pivoting mechanical cover that are supported by base construction to provide unidirectional blood flow, such as in the U.S. Patent No. 6 of the people such as Stobie, 143, the U.S. Patent No. 6 of the people such as 025 and Brendzel, 719, shown in 790, the whole open of these patents is incorporated to herein by reference clearly.Another kind of type is organization type or " artificial creature " valve, it has and to be supported by base construction and the flexible leaflet protruded in flowing stream, flexible leaflet function and natural human heart valve's function extraordinary image, and the natural flexing motions of simulating them is to engage (coapt) relative to each other and to guarantee unidirectional blood flow.

In organization type valve, overall xenograft valve (such as, pig) or multiple xenograft leaflets (such as, bovine pericardium) can provide fluid occluding surfaces.Proposed the lobule synthesized, and therefore term " flexible leaflet valve " refers to natural and artificial " organization type " valve.In typical organization type valve, two or more flexible leaflet are installed in peripheral support structure, and peripheral support structure generally comprises and extends with column or the Colaesce (commissure) of simulating natural fiber Colaesce along flowing out direction in natural lobe ring.There is sometimes referred to as " support frame " of the metal of " metal wire frame " or " support " or " support frame " of polymerization multiple (being generally three) the large radial point in supporting flexible leaflet tip region (such as, overall xenograft valve or three independent lobules).The end of often pair of adjacent cusps a little progressively converges to form the upstanding commissures terminating in top, and each Colaesce all extends and has relatively little radius on the direction contrary with arcuate tip.The assembly of valve usually with one or more bio-compatible fabric (such as, poly terephthalic acid diethyl alcohol ester (PET)) covering assembles, the suture ring that the inflow end of peripheral supporting construction provides fabric to cover.

An example of flexible leaflet valve structure sees the U.S. Patent No. 6 of the people such as Huynh, 585,766 (bulletins on July 1st, 2003), wherein the decomposition view of its Fig. 1 illustrates the metal wire frame 54 that the fabric on the either side of lobule sub-component 52 covers and the supporting bracket 56 that fabric covers.U.S. Patent No. 6,585, the content of 766 is incorporated to herein by reference with its entirety.Other examples of valve and associated component/system see the U.S. Patent No. 4,084,268 at bulletin on April 18th, 1978; In the U.S. Patent No. 7,137,184 of bulletin on November 21st, 2006; In the U.S. Patent No. 8,308,798 of December in 2009 submission on the 10th; In the U.S. Patent No. 8,348,998 that on June 23rd, 2010 submits to; With the U.S. Patent Publication No.2012/0065729 submitted on June 23rd, 2011; Each full content in above patent is incorporated to herein by reference with its entirety.

Sometimes, after patient has had the comparatively early valve replacement of identical valve, the needs that whole valve is replaced may have been there are.Such as, successfully implant to replace natural valve Cardiac valve prosthesis this may sustain damage and/or wearing and tearing in the many years after implanted at first.In the Cardiac valve prosthesis implanted formerly, directly implanted prosthetic heart valve may be unpractical, partly cause is that new Cardiac valve prosthesis (comprising supporting construction and valve assemblies) must be positioned at the valvular lobe ring previously implanted, and traditional Cardiac valve prosthesis may not be configured to easily receive this valve to be implanted at valve as follows, this mode is for new valve provides firm arrangement also to have enough large lobe ring to support by suitable blood flow wherein in new valve simultaneously.

The problem being implanted into new valve at old valve has caused some to pay close attention to.Particularly, below patent discloses the various solutions for lobe mesopetalum system: Konno is at the U.S. Patent Application Publication No.2010/0076548A1 of JIUYUE in 2008 submission on the 19th; And the U.S. Patent No. 8,613,765 that Bonhoeffer submitted on July 7th, 2011.

Although have some to improve in lobe mesopetalum field, but still there are the needs identifying rapidly the valvular physical characteristic previously implanted, comprise the surgery valve previously implanted and whether be suitable for lobe mesopetalum program.

Summary of the invention

The disclosure solves the some problem of the identification of the Cardiac valve prosthesis after about implantation.Cardiac valve has indicator thereon, and this indicator passes through outside imager after the implantation from external.Indicator passes on size or the orifice diameter of surgery valve, and can illustrate that valve has the ability implanting rear expansion.Indicator can also pass on other information, such as manufacturer and/or valve model, for making artificial creature's tissue or the combination in any of the type of other materials and the compatibility of valve and other types valve of lobule.Indicator can be alphanumeric symbol and/or other symbols one or more representing the large decimal fractions of such as valve and other characteristics.

This application discloses the specific amendment to existing surgery valve, this amendment can make manufacturer produce the valve adapting to lobe mesopetalum (ViV) program fast.Particularly, discloseder embodiments comprise transformation or the parts that are modified in the surgery valve of existing type expanding after the implantation in this application.

In an embodiment of the application, Cardiac valve prosthesis comprises inner support frame, and it limits the flow orifice passed therethrough, and wherein this inner support frame is applicable to expand after the implantation.Multiple flexible leaflet is attached to support frame to extend through flow orifice and join in aperture and provide the one-way flow passed therethrough.Cardiac valve prosthesis comprises valve types indicator further, and this indicator provides the information about valvular characteristic and uses outside imager visible.Valve types indicator can represent the ability of the support frame expanded after the implantation for aperture.

Cardiac valve prosthesis is the markd valve size of tool preferably, and valve types indicator comprises valve size indicator, the valve size of valve size indicator cue mark and use outside imager visible or readable.Such as, valve size indicator comprises the digital value of the labelling valve size equaled in units of millimeter.In one embodiment, inner support frame is included in the structure member outside imager being shown as erect image, and valve types indicator is formed by being incorporated to one or more space of structure member, and one or more space is shown as negative-appearing image on outside imager.Such as, the structure member of inner support frame can be generic tubular band, and this generic tubular band is applicable to expand after the implantation.In certain embodiments, valve types indicator is such as incorporated to structure member to provide erect image as a part for band, support and/or metal wire frame.

In another embodiment, valve types indicator is included in the indicator component outside imager being shown as erect image, indicator component is installed to the structure member of Cardiac valve prosthesis, structure member is not obvious visible to outside imager, makes valve types indicator form contrast with structure member on outside imager and illustrates.Such as, structure member comprises the soft sealing ring flowing into end around cardiac valve, and indicator component is installed to sealing ring.

On the one hand, Cardiac valve prosthesis comprises the expandable tubular framework being attached to inner support frame inflow end further, and valve size indicator is positioned on expandable tubular framework.In this configuration, expandable tubular framework can have a series of circumferential and axial pillar, wherein upper strut is configured as the peak portion and valley that have around its periphery, and below upper strut and axially in pillar one of valve types indicator is incorporated to framework as label.That expandable tubular framework is desirably metal and formed by cut, wherein label is identical with frame material and formed during laser cutting parameter.

In another embodiment, Cardiac valve prosthesis disclosed herein comprises inner support frame, and it limits the flow orifice that passes therethrough and separated towards flowing into the bending multiple tips of end by Colaesce.Support frame comprises and is arranged on the ring-type element that support frame flows into end, ring-type element undulate thus have peak portion and valley, and wherein peak portion corresponds to the Colaesce of support frame.Multiple flexible leaflet is attached to support frame and extends through flow orifice, to join in this aperture and to guarantee the one-way flow that passes therethrough, each tip along support frame in lobule and Colaesce attached at peripheral edge place.Indicator is positioned on ring-type element, be such as arranged in the peak portion of ring-type element at least one on or be arranged at least one of valley of ring-type element, this indicator instruction valve types and use outside imager visible.

In one form, ring-type element comprises single expansible section, and this expansible section is formed by the free end overlap making of the tip being arranged in support frame to locate.Preferably, in each peak portion in the middle of each valley of ring-type element, identical indicator is being provided.The markd valve size of Cardiac valve prosthesis tool, and valve types indicator can comprise the digital value of the labelling valve size equaled in units of millimeter or represent the non-numeric symbols of the labelling valve size in units of millimeter.Ring-type element comprises the metal tape of generic tubular ideally, this metal tape is shown as erect image on outside imager, and valve types indicator is formed by the one or more spaces being incorporated to this metal tape, and one or more space is shown as negative-appearing image or erect image on outside imager.

Cardiac valve may further include and is attached to the expandable tubular framework that inner support frame flows into end, and wherein the second valve types indicator is positioned on this expandable tubular framework.Expandable tubular framework can comprise a series of circumferential and axial pillar, wherein upper strut is shaped as the peak portion and valley that have around its periphery, and valve types indicator is incorporated to framework as in label below upper strut and axially pillar.

Some embodiments provide Cardiac valve prosthesis, and it comprises: the inner support frame limiting the flow orifice passed therethrough, and inner support frame is applicable to expand after the implantation; Multiple flexible leaflet, it is attached to support frame and extends through flow orifice and join to limit the one-way flow passed therethrough in this aperture; And the valve types indicator of the information about cardiac valve characteristic is provided, valve types indicator uses outside imager readable.

Some embodiments provide Cardiac valve prosthesis, it comprises: the inner support frame limiting the flow orifice passed therethrough, inner support frame limits multiple tip, multiple tip is spaced apart and bending towards inflow end by Colaesce, support frame comprises the ring-type element being arranged on support frame inflow end place, ring-type element undulate thus there is peak portion and valley, wherein peak portion corresponds to the Colaesce of support frame; Multiple flexible leaflet, it is attached to support frame and extends through flow orifice and in this aperture, join the one-way flow guaranteeing to pass therethrough, each tip along support frame in lobule and Colaesce attached at peripheral edge place; And indicator, it comprises at least one feature in ring-type element, indicator there is the radiopacity at least partially different from the radiopacity of ring-type element, indicator instruction valve types and use outside imager visible.Ring-type element can be radiopaque at least partially, wherein indicator comprises at least one opening, and this opening extends through at least one radiopaque part of ring-type element.

Some embodiments are provided for the method for replacing the artificial valve just needed, and the method comprises: the valve types indicator reading the first artificial valve, select the second artificial valve, and dispose the second artificial valve based on the information read in the first artificial valve.Alternatively, before the method is included in deployment second artificial valve, same period or simultaneously, expand the diameter of the first artificial valve.

Accompanying drawing explanation

According to the following detailed description carried out by reference to the accompanying drawings, other features and advantages of the present invention will become apparent, and accompanying drawing illustrates principle of the present invention by way of example.

Figure 1A to Fig. 1 E is perspective view and the profile of the exemplary surgical Cardiac valve prosthesis of the application, and this exemplary surgical Cardiac valve prosthesis has the internal structure band that is suitable for expanding after the implantation and has from external visible valve size indicator on the inner member;

Fig. 2 is the side view of the exemplary surgical Cardiac valve prosthesis of the application;

Fig. 3 uses the schematic diagram with the image of the prior art Cardiac valve prosthesis of Fig. 2 same orientation seen by exogenic X-ray or other imagers;

Fig. 4 is the illustrative diagram picture similar with the image of Fig. 3 of the Cardiac valve prosthesis of the application, and it has the valve size indicator on inner frame parts, and this indicator uses X-ray or other imagers from external;

Fig. 5 A to Fig. 5 D is the front view for the different external support bands in the valve of Figure 1A to Fig. 1 E, wherein in the various positions of valve size indicator on support belt, this support belt has the overlapping free end kept together by friction sleeve, expanding after the implantation;

Fig. 6 A is the front view of alternative external support band, this support belt has the symbolization valve size indicator at a most advanced and sophisticated place in the tip of band thereon, and Fig. 6 B is the cipher table (keychart) for the connotation of decoding symbols valve size indicator;

Fig. 7 is the front view of further external support band, and this support belt has the multiple holes formed around its periphery, and the quantity in hole equals the valve size in units of millimeter;

Fig. 8 A is the front view of another external support band, and this support belt has the symbolization valve size indicator in a comissure in Colaesce thereon, and Fig. 8 B is the cipher table of the connotation for decoding symbols valve size indicator;

Fig. 9 A is another external support band, and this support belt has the symbolization valve size indicator in a comissure in Colaesce thereon, and Fig. 9 B is the cipher table of the connotation for decoding symbols valve size indicator;

Figure 10 is the front view of further external support band, and this support belt has multiple holes that a tip in tip provides, and the number in hole signifies concrete valve size;

Figure 11 A and Figure 11 B illustrates at least one having separately in tip the support belt of the single geometrical symbol formed, and geometrical symbol signifies concrete valve size;

Figure 12 is further external support band, has the Radiopaque coatings of the pattern adopting the concrete valve size of symbol thereon;

Figure 13 A to Figure 13 C is the perspective view of further Cardiac valve prosthesis support belt, and this support belt is instructed to for expanding after the implantation and having the overlapping free end kept together by friction sleeve, and Figure 13 D illustrates the expansion of overlapping free end;

Figure 14 A is the perspective view of the internal core component of Exemplary sutures ring, it illustrates the bar of the radiopaque material therefrom decomposed, bar can be incorporated to suture ring to indicate valve size, and Figure 14 B is for using from schematic top view seen by the X-ray of valve bodies outside or other imagers, it has as radiopaque bar indicated in Figure 14 A;

Figure 15 A to Figure 15 C is the valvular perspective view of the application Exemplary artificial and front view, some sectional views and phantom, and this Cardiac valve prosthesis has expansible lower frame, and expansible lower frame has valve size indicator thereon; And

Figure 16 is the perspective view of the lower frame of the valve size indicator with Figure 15 A to Figure 15 C.

Detailed description of the invention

Cardiac valve prosthesis as herein described comprises inside separately (with element is contrary as a supplement, its expression is merged in valve itself) support or framework, this support or framework are roughly tubulose in shape and limit flow orifice region, and blood flows to outflow end by this flow orifice region from inflow end.Alternately, the shape of internal stent can be avette, oval, irregularly shaped or any other intended shape.Valve preferably includes the flexible leaflet that selectivity allows fluid stream to pass therethrough.Therefore, flow orifice region alternately opens and closes via the motion of lobule.Cardiac valve can also comprise the outside or peripheral suture ring or sealing ring that are formed by the suture penetrable material of softness, and this suture ring or sealing ring are typically used as anchor valve to be fixed to natural lobe ring, but valve is other to be revealed to prevent can also to be mainly used in sealing.

As mentioned in this article, multiple difference configuration can be comprised according to the Cardiac valve prosthesis that equipment and the method for this invention use, such as there is one or more artificial creature's tissue leaflets (such as, cattle or pig) Cardiac valve prosthesis, there is the synthesis cardiac valve of polymer lobule, and be configured to replace native heart valve or the Cardiac valve prosthesis previously implanted usual any one.Cardiac valve prosthesis as herein described is generally used for replacing aortic valve, Bicuspid valve, Tricuspid valve and valve of pulmonary trunk, but also can be used as venous valve.These replacement prosthetic heart valves can also be used for functionally replacing without support biological valvular prosthesis.

In a preferred embodiment, inner valve support disclosed herein or support frame have " the expansible section " that can expand after the implantation.This can occur due to expansible section fracture, plasticity stretching, extension and/or elastic elongation.Therefore, " expansible section " represents the position making support in diametrically expansion (when such as expanding in support when sacculus) on support.Example comprise weakness, the weakened region of fracture or stretching, extension, elasticity or the plastic elongation that can rupture accordion-like structure, by the rent in support that component such as suture, weak chain or spot welding and other modes various keeps together can be disconnected.Therefore, term " expansible section " comprise these substitute in each.Such as, the U.S. Patent application No.14/136 of December in 2013 submission on the 20th, 318, and U.S. Patent Application Publication No.2010/0076548A1 and No.2011/0264207A1 discloses the various embodiments of expansible valve, the content of these patents is clearly incorporated to herein by reference.

Figure 1A to Fig. 1 E is the perspective view of the application Exemplary artificial cardiac valve 20 around flow axes 22 orientation of hypothesis and profile.Cardiac valve 20 comprises multiple (the being generally three) flexible leaflet 24 supported by corrugated metal reel 26 and structure stand 28 (Fig. 1 E) part.The combination of metal wire frame 26 and structure stand 28 limits the support frame of lobule 24.Metal wire frame 26 can be formed by suitable elastic metallic, and such as cobalt-chromium-nickel alloy (such as, alloy), and structure stand 28 can be metal, plastics or both combination.As best visible at Figure 1B, the supporting construction of metal wire frame 26 and support 28 limits the wavy periphery of Colaesce alternately 32 and most advanced and sophisticated 34, and lobule 24 is fixed to this wavy periphery.As seen in Fig. 1 D, the external tabs 30 of adjacent leaflets 24 extends and a part for winding-structure support 28 between the adjacent wire in the comissure of metal wire frame 26.Be covered with cloth and the Colaesce 32 of this formation of structure valve fixed with suture, Colaesce 32 projects upwards along flow axes 22 in outflow side.Each Colaesce 32 is positioned in the middle of two arcuate tip 34, and arcuate tip 34 bends towards inflow direction.Soft sealing ring or suture ring 36 are adjacent to most advanced and sophisticated 34 and just in time limit the inflow end of Cardiac valve prosthesis 20 from most advanced and sophisticated 34 radially outwardly, and may be used for using such as suture valve to be fixed to natural lobe ring.Metal wire frame 26 and structure stand 28 visible in the cross-section, and be usually covered with polyester textile as shown in the figure, to be conducive to assembling and to reduce direct blood after the implantation.

Fig. 1 E illustrates interior structural support 28, and support 28 comprises the assembly of two concentric annular lands in an illustrated embodiment: external belt 40 is around inner band 42 and be in contact with it.Although indicator as herein described may be used in many different Cardiac valve prosthesiss, shown structure stand 28 is the valvular structure stands for particular series; That is, the pericardium cardiac valve that manufactures of the Edwards Life Sciences, Inc (EdwardsLifesciences) of California Irvine.Such as, pericardium lobule 24 is utilized cardiac valve with the spitting image of the internal stent 28 shown in Fig. 1 E for feature.Radial dimension relative thin compared with axial dimension of annular support band 40,42, and there is the consistent lower edge axially fluctuated up and down around periphery.External belt 40 shows three tack peaks portion between three reclinate valley, and inner band 42 has roughly the same shape but also upwards extend at Colaesce column 44 place.As finding in fig. ie, the reclinate valley that two bands 40,42 limit is called most advanced and sophisticated 46 usually.The Cardiac valve prosthesis of much business comprises the support frame with ring-type element, and it will be understood by those of skill in the art that, the Cardiac valve prosthesis of business can be modified to include the indicator of the application.

Exemplary in valve, external belt 40 be metal (such as, cobalt-chromium-nickel alloy) and formed by elongated bonding jumper, bonding jumper bends to circular and has the free end welded together.On the contrary, external belt 42 by bio-compatible polymer such as mouldable polyester (PET) or polyacetals is formed, and can be formed as closed and become circular welding or the bar (not shown) of combination.Both external belt 40 and inner band 42 usually with a series of through holes aligned with each other for feature, assembly can be sewn to together.The Colaesce column 44 of metal wire frame 26 and inner band 42 provides flexible for valve commissures, which reduces the stress on the synthetic biomaterial of lobule 24.But, by suture ring 36 around the inflow end of valve 20 or pedestal comprise the circular portion of the relative stiffness of structure stand 28.The valve that is combined as of metal outer band 40 and plastics inner band 42 brings metastable circumferential pedestal dimensionally, and this pedestal is useful to typical purposes.But, for surgery valve provides these identical characteristics opposing valve expansion after the implantation of the structure stand 28 of good stability.Therefore, structure stand 28 can be modified to be conducive to its expansion, to use in lobe mesopetalum program.

The ability of the Cardiac valve prosthesis expansion of previous implantation is also unknown.In fact, this program is relatively new, and the valve that therefore major part is implanted also is not designed to radial dilatation.In addition, the surgical team that now frequently implanted expansible valve may be not easy considered lobe mesopetalum program identifies.Although keep a record to the surgical operation of each patient when each program, but bad archives preservation, the existence that between doctor and hospital, shortage exchanges, patient moves the even same country in not Tonzhou, emergency, and other factors may make those archives unavailable to surgical team subsequently after many years.In fact, may be not easy to obtain even if seem flat-footed information as the size of the Cardiac valve prosthesis previously implanted, carrying out exogenic imaging also may not provide accurately determining valve size.

Therefore, this application provides the various solutions for easily identifying Surgical heart valve in size and type.In a preferred embodiment, to the valvular size of major general to indicate on valvular parts from external visible mode after the implantation.As used herein, " visible " comprises the meaning of " readable ", " visual ", " detectable " and " explainable ".Such as, Fig. 1 E illustrates the size indicator 50 of each middle formation in the tip 46 of external belt 40.Valve size indicator 50 can make it pass radiopaque external belt 40 (negative-appearing image or erect image) by cutting hole or space and be formed, or by forming non-radiopaque material webs and adding radiopaque indicator (erect image) and formed.In some instances, all or part of of indicator is limited by the thinner region of external belt and/or thicker region, such as, does not make it pass external belt by cutting in external belt or fabrication design.Varied in thickness is selected for the abundant change providing the radiopacity of band, to allow indicator from external visual.Some substitute and comprise through hole and varied in thickness.The following describe various alternate design and encoding scheme.In this example, size indicator 50 comprises numerical character " 21 ", and its instruction valve aperture size is 21mm.For many years, cardiac valve size has been standardized as and has started with 19mm and larger patient to be risen to the millimeter increment of 31mm or 33mm.The application describes the valve size indicator following this convention, but should be appreciated that, can use the convention of other size criteria, and therefore this application should not be regarded as limited to the increment of these odd number mm in sizes.For term " valve size ", each Cardiac valve prosthesis has the mark size of instruction valve size (such as, be increment with 2mm between 19mm and 33mm), and there is the concrete valve model of the upper reflection of valve packaging, the Bicuspid valve of such as particular type.

Whether the parts in Cardiac valve prosthesis can also be made their instruction valves expansible by coding.But, should be appreciated that, those valves that valve size indicator can also be used for non-expansible valve and can expand after the implantation.Any valve surgery subsequently all has benefited from the knowledge of the cardiac valve size previously implanted.About the additional information previously implanting valve, such as manufacturer and/or valve model, and the compatibility of valve and other types valve are also useful and also can be coded on Cardiac valve prosthesis.

Fig. 2-4 illustrates the benefit providing indicator such as valve size indicator on surgery valve.Although anticipate dissimilar indicator, for the sake of simplicity, below valve size indicator is only described.But, should be appreciated that, provide and identify that the indicator of any form information is a part for invention described herein.Fig. 2 is the side view of assembled surgery valve 60, and surgery valve 60 can be the exemplary valve 20 shown in Figure 1A to Fig. 1 E, but also can indicate the surgery valve without any indicator.In other words, the embodiment of the surgery valve 20 of the application has size indicator in one or more internal part coideal, and size indicator uses imaging visible but invisible to naked eyes.Certainly, this does not get rid of the outside of the radiopaque valve size indicator of interpolation to valve, but some internal part as herein described is suitable for the placement of indicator better.Such as, make indicator become to be integrated with the structural detail of valve the similar assembling process being allowed for non-indicator valve, and maintain similar parts count.The hematodinamics of indicator also not materially affect valve is comprised in inside.In fact, be also not precluded within valve outside to macroscopic valve size indicator, show under imaging after the implantation although this type of indicator is unnecessary.

Fig. 3 uses the schematic diagram with the image of the prior art Cardiac valve prosthesis of Fig. 2 same orientation seen by exogenic x-ray imaging device or other imagers.X-ray imaging device is identified in those assemblies being generally metal in cardiac valve, these assemblies block X-ray spectral radiance.Be similar in above-mentioned valvular illustrated embodiment at surgery cardiac valve, x-ray imaging device presents interior metal reel 62 and support belt 64.Stop that the part of X-ray beam is darker than the display of other parts.The prior art valve of Fig. 3 does not have size identifier thereon, and therefore checks that the surgeon of this image needs to carry out experienced supposition about concrete valve size.Consider that valve is produced as and has the aperture size being only increment with two millimeters, some difficulty of this task.

On the other hand, Fig. 4 is the screenshot capture of the radioscopic image of the Cardiac valve prosthesis 20 of Figure 1A to Fig. 1 E.Again, x-ray imaging device irradiates both metal wire frame 26 and external belt 40, but valve size indicator 50 also occurs.Namely, indicator 50 comprises the numeral " 21 " in each tip be cut in three tips 46 of band 40.Because indicator 50 is all provided, so they can be seen expediently from different orientation in all three tips.Therefore, surgeon can easily identify valve size 21mm, and correspondingly proceeds.To describe as following, supplementary features may be provided on the radiopaque parts of Cardiac valve prosthesis 20, and supplementary features indicate its expansivity and may be displayed on radioscopic image as seen in Figure 4.

Detect comprising for the term " imager " (" outside imager ") from external use of indicator, from any equipment of the discrete component in external visualization body, any equipment for radiology field that can produce this type of image can be generally.These fields comprise the x-ray imaging of the X-ray of seeing reflection or fluoroscopy, nuclear magnetic resonance, medical ultrasonic inspection or ultrasound wave and nuclear medicine functional imaging technology such as positron emission tomography.Term " imager " also comprises following equipment or system, namely comprises equipment or the system of at least one parts (such as ultrasonic transmitter) be arranged in patient body.

As previously mentioned, this document describes that the various of valve size indicator substitute.Fig. 5 A to Fig. 5 D is the front view of the external support band of valve for Figure 1A to Fig. 1 E, and these external support bands have the valve size indicator in various position thereon.Fig. 5 A illustrates above-mentioned external belt 40, and external belt 40 all has valve size indicator 50 on its all three tips 46.Again, valve size indicator 50 comprises " 21 " through the cutting of metal tape 40 thickness, and its image with negative film display in X-ray, will be formed with dark color " just " reflecting part of the remainder of band and contrast.Although it should be noted that identical indicator (in this case, valve size is " 21 " mm) is illustrated in three whole positions, also different indicators can be used.Therefore, the different symbol of dissimilar identifying information is provided to may be provided in along in three diverse locations of band.Should be appreciated that, indicator can be positioned at along band Anywhere, and not only in most advanced and sophisticated and/or comissure, and band can comprise the indicator of any number.

External belt 40 comprises two the overlapping free ends 66 kept together by friction sleeve 68.This allows band 40 to expand and one that therefore allows whole valve 20 to expand possibility embodiment.More details about this layout will be provided below.But, it should be noted that inner band 42 (Fig. 1 E) is also preferably incorporated in the enlarging property at the same position place of external belt expansion.The example of the suitable enlarging property of inner band comprises, the structure of expansion or easily fracture.Such as, as referring to figure 1e, inner band 42 is with the breakdown point of such as recess 69 for feature, and recess 69 is positioned at a tip 46 place of band structure.Recess 69 represents the transverse cross-sectional area reduced, and by applying enough outward expansion forces from inside, this region may be broken or stretch.Such as, the sacculus for making the second artificial valve expand in surgery valve can provide enough outward forces to rupture or stretching, extension at recess 69 place to make inner band 42.The material of inner band 42 can be relatively frangible, make excessive pulling force cause recess 69 to break, or this material can have more ductility, and ductility allows recess 69 to stretch with the mode plasticity of taffy.

Fig. 5 B and Fig. 5 C illustrates alternative external belt 70,72 respectively, and external belt 70,72 has single size indicator 74,76 thereon.In the previous case, the single size indicator 74 of numeral " 21 " form is by a tip in the tip 76 of incision band 70.In the case of the latter, single size indicator 77 has been migrated to one in the tack Colaesce 78 of band 72.Valve size indicator 74,76 can be placed in any position, although at Colaesce 78 place available more a little material.In addition, the size indicator 76 in band 72 cuts the thickness of threading completely, and can simultaneously as the replacement of hole or opening 80, and hole or opening 80 are provided at comissure usually external belt is attached to inner band with suture.Fig. 5 D illustrates the band 82 similar with the band shown in Fig. 5 C, but in band 82, all there is valve size indicator 84 at each tack Colaesce 86 place.

Fig. 6 A illustrates the further example of external support band 90, and external support band 90 has the symbolization valve size indicator 92 being arranged in most advanced and sophisticated 94 1 most advanced and sophisticated places.In this case, valve size indicator 92 comprises a pair geometry in incision band 90, and this indicates valve size together to geometry.Fig. 6 B illustrates the exemplary cryptographic table of the connotation for decoding symbols valve size indicator 92, and this cipher table can be provided in together with valve and such as on webpage or other addressable positions the surgeon attempting to decode this indicator can be used.Such as, various geometry is mated with individual digit by the first row of cipher table, and corresponds to first or left side indicator symbol and the first bit digital in the large smallest number of valve.Equally, secondary series corresponds to the second-order digit of second or right side indicator symbol and the large smallest number of valve.In the embodiment shown, left side indicator symbol is circular, and right side indicator symbol is square.Therefore, the first bit digital corresponding to the circular large smallest number of valve is 2, and the second-order digit corresponding to the large smallest number of foursquare valve is 1, makes indicated valve size for " 21 " or 21mm.The numerical character that can easily be distinguished from each other when being used in imaging relatively large and simple geometry can be mispronounced than sometimes (such as, will " 1 " and " 7 " distinguished) more preferably.In other embodiments, use other schemes being used for encoding information, such as, in any direction, read the identical palindrome (palindromic) scheme.In other schemes, coding is selected such that the character string of backward read is not mapped to the expression of different size.

Term " space " refers to and is formed into or cuts in radiopaque support belt as herein described, or numeral in other radiopaque inner members of valve support frame, hole, geometrical symbol or other symbols.By being cut in space in other solid element, when visible by outside imager, indicator will be shown as negative-appearing image.Such as, the geometry formed in the numerical character " 21 " shown in the band 40 of Fig. 5 A or the band 90 at Fig. 6 A is included in the space in the other solid exterior profile of band.Erect image can also use the otch be suitably shaped to generate.Some embodiments use the combination of erect image and negative-appearing image, such as, to encode to dissimilar information, and/or distinguish the first numerical digit and the second numerical digit clearly.

Fig. 7 illustrates another external support band 96, and it has the multiple holes 98 formed around its periphery, and the number in hole 98 equals the valve size in units of millimeter.In other words, valve size is provided to the enumerate of hole or opening 98.In an illustrated embodiment, although all do not illustrate, there are 23 holes, make valve size be 23mm.For the existing hole 99 in comissure attached together for band is included in counting ideally to avoid confusion.In where case in office, opening is equidistantly arranged without the need to around tape.Such as, in some versions, the position of around tape is assigned with level, and each level was filled before next level.Such as, in a kind of scheme, first three positions in comissure are filled up, and are then the clockwise positions of Colaesce etc., make opening be grouped into three set of difference 1 opening at most.This scheme contributes to the exact number determining opening.

Fig. 8 A illustrates the further modification of external support band 100, and external support band 100 has the symbolization indicator 102 in a comissure in Colaesce 104 thereon.In this case, comprise one of them geometry pattern of existing suture hole to be cut to represent each size.Fig. 8 B is the cipher table of the connotation for decoding symbols valve size indicator 102.In an illustrated embodiment, pattern comprises a square and two circles, and this pattern corresponds to 21mm.

Fig. 9 A is further external support band 110, and it has the symbolization indicator 112 in the comissure being arranged in Colaesce 114.In this embodiment, again comprise existing suture hole one of them point and the pattern (being similar to Morse code) of dash/dash for representing each valve size.Fig. 9 B is the cipher table of the connotation for decoding symbols valve size indicator 112.Shape in incision Colaesce 114 comprises dash and two points, and it corresponds to the size of 21mm.The use of dash and point can be schemed more easily to understand, instead of attempts the different geometries that distinguishes as shown in Figure 8 A.

In Fig. 10, external support band 120 is with multiple hole 122 for feature, and multiple hole 122 is provided on a tip in tip, and the number in hole 122 signifies concrete valve size.Although not shown, cipher table can be provided to decode to this symbol.But usually, cardiac valve starts with 19mm and rises with 2mm increment, and therefore use a point to represent 19, the convention that two points represent 21 grades can become fine understanding.Therefore, shown symbol, two holes 122, corresponding to the size of about 21mm, or secondary little valve size.Equally, three holes can correspond to the valve size of 23mm, etc.As discussed above, hole or opening, without the need to adjacent, such as, can be distributed and/or be grouped to identify faster.

Figure 11 A and Figure 11 B illustrates support belt 130,140 respectively, and each support belt has the single geometrical symbol formed at least one tip, the valve size that this symbolism is concrete.Particularly, the band 130 in Figure 11 A is with the symbol 132 of circular form for feature, and it can indicate the valve size of 19mm, and the band 132 in Figure 11 B with the symbol 134 of square form for feature, it can indicate the valve size of 21mm.Again, cipher table can be provided, or symbol can become general in the industry, makes surgeon will identify rapidly their connotation.

Figure 12 illustrates the external support band 150 with Radiopaque coatings 152 thereon, the concrete valve size of pattern emblem of coating 152.In an illustrated embodiment, except two gaps 154 single bar 156 and the remainder of coating separated, coating 152 completely around tape 150 extends.The number in gap 154 indicates valve size in the mode similar with the number in the hole 122 provided in the band 120 of Figure 10.Namely, two gaps 154 in the embodiment shown correspond to the valve size of 21mm, and single gap can correspond to the less valve size of 19mm, and three gaps correspond to 23mm.In this embodiment, with preferably described in metal, other are with contrary, the material of band 150 is not intrinsic radiopaque.Such as, band 150 can be formed to provide required intensity by the polymer of relative stiffness, but this polymer does not show in X-ray.

Figure 13 A to Figure 13 C is the perspective view of the further Cardiac valve prosthesis support belt that can expand after the implantation, and these support belts have indicator thereon for size and expanding ability.Figure 13 A illustrates the support belt 160 all at each most advanced and sophisticated 164 places with digital valve size indicator 162, and one or more symbol 166 uses outside imaging visible and the expanding ability of instruction at each Colaesce 168 place.In an illustrated embodiment, symbol 166 comprises a succession of three holes comprising existing suture hole, and inner band and external belt link together by suture hole.The program allows to consider that the surgeon of replacement operation confirms rapidly the probability of lobe mesopetalum program, and confirms existing implantation valve size.

Figure 13 B illustrates external belt 170, and it has the little depression or concave surface 172 that are formed at the place of peak portion of tack Colaesce, depression or concave surface 172 different with the convex peak portion of rule, those peak portions seen by the comissure of convex peak portion such as band described elsewhere herein.Concave surface 172 indicates the ability of valve expansion after the implantation.This relatively large surface area changing the external belt 170 utilized in Colaesce region, and do not affect valvular function.

Finally, in Figure 13 C, support belt 180 has the size indicator around its periphery again, easily to be identified in the body after the implantation by outside imaging.Compared with band 160, support belt 180 with the arc slit 182 raised up in each comissure for feature.Again, this indicator 182 by using outside imaging by easily visual, and clearly can indicate this particular valve expansible to surgeon and is suitable for lobe mesopetalum program.

Figure 13 D is illustrated in detail in the interaction between two overlapping free ends 190,192, and free end 190,192 is positioned at a most advanced and sophisticated place of any one band as herein described, and they relative to each other slide and allow corresponding cardiac valve expansion.Free end 190,192 is roughly rectangle in shape, and free end radial direction to be present in another free end and against another free end.Sleeve 194 is around free end 190,192 and their radial directions kept together.Sleeve 194 comprises polyester (such as, PET) ideally and shrinks trocar sheath, can be maybe elastomeric material such as silicone rubber, and is illustrated as the transparent free end 190,192 to illustrate coupling.Two free ends 190,192 can slide separately preset distance but still overlapping.Flexible sleeve 194 provides minimized friction amount, but is generally used for maintaining free end 190,192 alignment.Each slit 196 comprising circumferential orientation further in free end 190,192, slit 196 does not arrive (free end 190,192) final end (stopsshortofterminalends) and provide passage for fluid stream.Slit 196 stretches out further from sleeve 194, makes fluid can enter space in sleeve always.At memory period, slit 196 allows the fluid between overlapping free end 190,192 to flow to allow sterilization.About rupture strength, the ferrule configuration in Figure 13 A to Figure 13 B can need about 1.2atm (atmospheric pressure) and at about 0.5atm to the mean burst pressure within the scope of about 2.0atm.Further, sleeve 194 can be biodegradable, aligns a period of time, and then degrade to allow to be with easy expansion to maintain two free ends 190,192 after the implantation.

Here it should be noted that, be described as identifying that the valve types indicator of expansible valve can also be used for providing further valve types information herein.Such as, indicator can illustrate the type of artificial creature's tissue or the other materials used in valve, valve manufacturer and/or model, the compatibility etc. of valve and other valves.Whether therefore, term " valve types " refers to the distinctive information of any valve, and be not only valve and can expand.

Figure 14 A is the perspective view of the internal core component 200 of the Exemplary sutures ring used in cardiac valve as described herein, internal core component 200 have be shown in the radiopaque material strips 202 of decomposing above, bar 202 can be merged in suture ring to indicate valve size.In an illustrated embodiment, radiopaque material strips 202 is provided with single elongated bar 204 short bar 206 relative to two.By assemble against core component 200 these 204,206, they can be visualized to indicate valve size by using outside imaging, and wherein core component 200 was usually coated with the fabric of bio-compatible before fitting together with valvular remainder.Such as, Figure 14 B uses from schematic plan seen by the x-ray imaging device of valve bodies outside or other imagers, and it has as radiopaque bar 204,206 indicated in Figure 14 A.Bar 204,206 shows dark around the dark metal parts (lobe ring) that is similar to of valve, and can be interpreted as determining valve size.Such as, two short bars 206 create three gaps 208 around suture ring, and it can represent the valve size (gap equals 19mm, and two gaps equal 21mm etc.) of 23mm.Alternately, radiopaque pearl (radiopaquebead) can be used as indicator.This embodiment represents other modes many, wherein can use any one no matter in essence whether in radiopaque inner valve parts by valve size coding in valve.Some embodiments are used in the combination of radiopaque bar in suture ring or pearl (bead) and the otch in band, and this allows the redundancy encoding to encoding additional information and/or more more important information.

Figure 15 A to Figure 15 C illustrates the further surgery Cardiac valve prosthesis 220 of the application, and it has expansible lower frame 222, and wherein valve types indicator 224 is arranged in lower frame 222.Cardiac valve 220 comprises the top valve member 226 being connected to lower frame 222.Valve types indicator 224 can on top valve member 226 or lower frame 222, or on both.In a preferred embodiment, cardiac valve 220 and framework 222 can be expanded with the lobe mesopetalum program can carried out as described elsewhere herein.Lower frame 222 is designed to expand during the initial implantation of valve 220, and valve member 226 and framework 222 are both expanded during lobe mesopetalum program subsequently.Namely, top valve member 226 is not intended expansion, and to implant at first and period of working works very similarly with typical non-collapsible/non-expansible surgery valve, but it comprises when suffering from inside such as from the feature making to allow during the large force radially of inflation limited amount expansion.Lower frame 222 can be made up of plasticity expandable material, such as rustless steel or cochrome, or can self expandable material such as nickel.

Top valve member 226 to be included in the sectional view of Figure 15 B the inner periphery support frame shown in part ideally, and this framework limits the upright Colaesce column 230 of three of replacing with three arcuate tip 232.Colaesce column 230 projects upwards in outflow side and supports the external margin of three flexible leaflet 234, and flexible leaflet 234 is for clarity sake removing shown in Figure 15 B in Figure 15 A.Lobule 234 is desirably artificial creature's lobule separately; Such as cut down from the bovine pericardium sheet material processed, and separately with arcuate tip edge and two commissure edges or tab for feature, wherein arcuate tip edge is attached along one of them in the arcuate tip of support frame, and wherein two commissure edges or the attached adjacent Colaesce column 230 of tab.The free edge 236 of each lobule is suspended between adjacent Colaesce column 230, and contacts with the free edge of other lobules or engage to form one-way flow valve being limited in the flow orifice in peripheral support frame.

In a preferred embodiment, support frame is limited by corrugated metal reel 240 and structure stand 242 part, and metal wire frame 240 limits Colaesce column 230 and extends around generally tubular region, and structure stand 242 can comprise endless belt; The parts similar to those parts shown in 62 in figure 3 and 64.Metal wire frame 240 can such as cobalt-chromium-nickel alloy be (such as by suitable elastic metallic alloy) make, and structure stand 242 can be metal, plastics or both combination.As in Figure 15 B finding, the external tabs 244 of adjacent leaflets 234 extends and in the part of Colaesce column 230 place winding-structure support 242 below metal wire frame 240.Soft sealing ring or suture ring 246 limit the inflow end of Cardiac valve prosthesis 130, and are generally used for such as using suture valve to be fixed to natural lobe ring.The metal wire frame 240 of support frame and structure stand 242 part in the profile of Figure 15 B is visible, and is usually coated with polyester textile 248 to contribute to assembling and to reduce direct blood after the implantation.

Cardiac valve prosthesis 220 is considered to " mixing " type, because it comprises the top valve member 226 with typical surgery valve like configurations, top valve member 226 has the metastable diameter being usually not intended to be compressed or expand, and valve is anchored to appropriate location for distensible with help by the lower frame 222 connected.A kind of specific business Cardiac valve prosthesis constructed by this way is the Edwards with the EdwardsLifesciences from California Irvine valve system combines a kind of Cardiac valve prosthesis of sale.Edwards valve system comprises " mixing " valve, " mixing " valve comprises the surgery with rustless steel lower frame construction -shape valve.But, with typical Edwards valve is compared, and valve member 226 is modified with any one in mode described herein, to allow to expand after the implantation to use in lobe mesopetalum program.Further, cardiac valve 220 comprises size indicator and is beneficial to this class method.

The concrete perspective view illustrating lower frame 222 with reference to Figure 16, Figure 16, lower frame 222 comprises the multiple circumferential row pillars connected by a series of isolated axial row pillar.Particularly, up pillar 250 or flow out row pillar 250 and extend continuously around the periphery of framework 222, and preferably follow mild undulated path to mate the analogous shape on the downside of top valve member 226.As visible at Figure 15 C, three peaks portion 251 along up pillar 250 corresponds to the position of the Colaesce 230 of valve 220, also upwards raises at these position pillars 242.Usually, lower frame 222 is attached to the inflow end of top valve member 226, and is preferably directly attached to inner support frame or is attached to the fabric of covering internal support frame.In the accompanying drawings, lower frame 222 is roughly tubulose, and expansion becomes conical butt a little when disposing, and wherein expands outwardly from top valve member 226 free end farthest, but nearest end keeps approximately identical diameter.Alternatively, lower frame is curled into conical shaped in advance, and wherein the diameter of free end is less than the diameter of up pillar 250, and up pillar 250 is not radially compressed substantially.

Up pillar 250 comprises multiple eyelet 252, and in the embodiment shown, multiple eyelet 252 uniform intervals is opened and is just positioned at below its top, and eyelet 252 can be used for such as using suture that framework 222 is fixed to the fabric on the downside of valve member 226.A series of axial row pillar 254 is from up pillar 250 and dangle downwards from each eyelet 252 particularly, and up pillar is connected to two descending pillars 256.Descending pillar 256 is with zigzag pattern limiting frame 222, and this pattern has " V " shape of reversing between every two adjacent column pillars 254.Descending pillar 256 preferably horizontal-extending, and the length of post 254 of being therefore disbursed from the cost and expenses changes along with wavy up pillar 250.

As mentioned above, lower frame 222 can be the such as plastic expansion by balloon expandable, and can be formed by such as rustless steel or cobalt-chromium alloy.At typical Edwards in valve, up pillar 250 be roughly ring-type but without expansion ability.On the other hand, in illustrated framework 222, provide a series of intervals recess 260 allowing expansion.Namely, the circumferential section of pillar 250 is interrupted by V-arrangement recess 260, and this allows limited amount expansion, such as, diametrically expanding about 3mm, with hold insertion wherein and expand wherein supplement expansible valve.

In addition, multiple valve types indicator 224 (such as three valve size indicator) is being integrated in framework 222 around the position of framework 222 periphery.In an illustrated embodiment, valve size indicator 224 comprises the platelet-like label of the digital valve size be carved with in units of mm, such as, be carved with 21mm in an illustrated embodiment.Anticipate to use and represent valve size and/or the alphanumeric character of other features and/or the combination in any of symbol.Framework 222 can from tubular blank cut, the size indicator 224 of wherein left tabular is connected to more than one pillar.As shown in the figure, size indicator 224 is just in time positioned at the below in the peak portion 251 of wavy up pillar 250, is connected to the eyelet 252 of correspondence and being disbursed from the cost and expenses between post 254 of declining.Therefore three size indicator 224 are spaced apart with about 120 ° around framework 222.Position shown under peak portion 251 provides additional space between up pillar 250 and adjacent descending pillar 256.Further, framework 222 has the more standing part (realestate) placing size indicator 224 wherein usually than the band of valve member 226.The large decimal fractions of the valve being carved into or cutting into is enough large thus use X-ray, transesophageal echocardiography (TEE) or other imaging technique is visual.In one embodiment, the height of the large decimal fractions of valve is from about 1.5mm to about 2mm, such as, be approximately 1.75mm.

Should be appreciated that, as the replacement of the digital valve size indicator of incision label, any one in above-mentioned size indicator can also be used in identical position.This situation about being integrated in existing structure instead of as the independent adnexa needing independent attachment steps for indicator is particularly useful.This not only reduces built-up time and cost, but also guarantees that indicator is positioned at visual ideal position, and does not require alignment procedure.Such as, various indicator disclosed herein is cut or prints to each metal parts, or by providing reflectance coating etc. to distinguish on parts.

It is noted that there are many modification of above-described embodiment, comprise many combinations of various embodiment, they all within the scope of the invention.Such as, the various numbers and symbols indicators of valve size or valve types can be provided to suture ring as radiopaque additament, or usually carry out as required mixing and mating.And specific support structures can have the combination in any of expansible part discussed above.

As discussed earlier, at least one size indicator can be made up of any suitable material, such as, and radiopaque material or radiopaque impregnated material.Select the radiopaque material being used for this object can be bio-compatible.This type of material comprises rustless steel, tungsten, tantalum, platinum, gold, barium silicate, and alloy, and such as cobalt-chromium (such as, alloy) or high-performance nickel alloy is (such as, alloy).

There are the various techniques being used for being formed radiopaque mark by this class material.In certain embodiments, etch process may be used for creating signage articles.This technique can be light etching process, thus photoresistance coating is applied to photosensitive polyester sheet as mask.Light projects on this plate, and then rinses this plate to remove the photoresist as mask.Then, additional rinsing step may be used for chemistry and removes a part of metal being exposed to light.In other embodiments, the metal of photoresistance coating and exposure can be removed in a rinsing step.Other similar etch process known to those skilled in the art can be used.

Another kind of mechanism for being created in the radiopaque goods used in described mark relates to by radiopaque material sheet pressed part.Such as, raw band can be sent into the module with projection and recessed portion printing off character.Use Sheet Metal Forming Technology, removal, polishing may be needed or clean any Roughen Edges and/or burr that generate thus.

As already mentioned, the another kind of technology for the production of radiopaque goods relates to use laser cutting technique.Cut can produce pole tighter tolerances and smooth edges, thus contributes to the readability of little radiopaque mark.But some materials can be expensive or use this technology to be difficult to process.Particularly, this technology can be expensive in higher batch production level.

Another selection for creating radiopaque goods relates to sintering process.According to this technology, the Powdered radiopaque material mixed with glue is pressed into a kind of form and fires, until all glue dissipated and radiopaque particle adherence together.This kind of technique creates loose structure, and loose structure more easily adheres to the molecule of the polymer used during molding process subsequently, and wherein pore receives the degree of polymer to depend on the molecular size of polymer.

Metal injection molded can also being used for creates radiopaque goods.In this case, radiopaque powder or suspension are injected in mould under stress.Then, powder or suspension are fired, until radiopaque goods are bonded to each other.The same with sintering, it can produce the radiopaque goods of relative porous.

Artificial valve may be lost efficacy due to many reasons or be out of order, such as, and narrow, pannus growth, reflux and/or mechanical breakdown.In such cases, displacement can be expected.Selection be remove fault artificial valve's (such as, in operating mode) and in its position, implant new artificial valve.Another selects to be perform so-called lobe mesopetalum program, in this procedure, does not remove fault valve in the implanted fault valve of new valve.Wherein new valve is transcatheter valve, and this program can use and cause Wicresoft's program of very little wound to perform to patient.Although in fact fault valve does not remove, this program is commonly called " displacement ", because new artificial valve instead of the function of fault valve.

The embodiment of the method for the first artificial valve just needed for using the second artificial valve replacement comprises, read the valve types indicator of the first artificial valve, select the second artificial valve based on read information, and dispose the second artificial valve in the first artificial valve.First artificial valve comprises any artificial valve comprising valve types indicator, comprises any embodiment as herein described.Valve types indicator can have the combination of any type or type described herein, such as, and size, expansivity, manufacturer, model or any other information expected.As mentioned above, valve types indicator be read, imaging or visual.

Alternatively, the diameter of the first artificial valve is expanded, such as, before disposing immediately preceding use second artificial valve, with its same period (contemporaneously) or simultaneously (simultaneously).In some instances, the first artificial valve such as passed through to use sacculus by mechanical expansion before the second artificial valve disposes.In other examples, the deployment of the second artificial valve itself makes the expanded in diameter of the first artificial valve.In certain embodiments, the second artificial valve is transcatheter cardiac valve, and such as, balloon expandable or self expandable are through catheter heart valves.Alternatively, the second valve is expanded after deployment, to improve the joint between the first valve and the second valve.

Although describe this invention about specific embodiment, should be appreciated that, can make a variety of changes and additional variations, and equivalent can substitute its element, and not deviate from the scope of the invention or its inventive concept.In addition, many amendments can be made and be applicable to instruction of the present invention to make specific situation or equipment, and not deviate from its elemental range.Therefore, the present invention is not intended to be limited to specific embodiment disclosed herein, but the present invention will comprise all embodiments fallen in appended claims.

Claims (24)

1. a Cardiac valve prosthesis, it comprises:

Inner support frame, it limits the flow orifice passed therethrough, and described inner support frame is suitable for expanding after the implantation;

Multiple flexible leaflet, it is attached to described support frame and extends through described flow orifice and join to limit the one-way flow passed therethrough in described aperture; And

Valve types indicator, it provides the information about described valvular characteristic, and described valve types indicator uses outside imager readable.

2. cardiac valve according to claim 1, the markd valve size of wherein said Cardiac valve prosthesis tool, and described valve types indicator comprises valve size indicator, and described valve size indicator indicates the valve size of described labelling.

3. cardiac valve according to claim 2, wherein said valve size indicator comprises the digital value of the valve size of the described labelling equaled in units of millimeter.

4. the cardiac valve according to any one in claims 1 to 3, wherein said inner support frame comprises structure member, described structure member is shown as erect image on described outside imager, and described valve types indicator is formed by the one or more space be incorporated in described structure member, and described one or more space is shown as negative-appearing image on described outside imager.

5. cardiac valve according to claim 4, the described structure member of wherein said inner support frame comprises the band of generic tubular, and the band of described generic tubular has distensible diameter after the implantation.

6. the cardiac valve according to any one in claim 1 to 5, wherein said valve types indicator is included in the indicator component described outside imager being shown as erect image, described indicator component is installed to the structure member of described Cardiac valve prosthesis, described structure member has differentiable outward appearance on described outside imager, described valve size indicator and described structure member is formed on described outside imager and contrasts.

7. cardiac valve according to claim 6, wherein said structure member comprises around the described valvular soft sealing ring flowing into end, and described indicator component is installed to described sealing ring.

8. the cardiac valve according to any one in claim 1 to 7, wherein said valve types indicator represents the ability of the described support frame expanded after the implantation for described aperture.

9. the cardiac valve according to any one in claim 1 to 8, wherein said Cardiac valve prosthesis comprises further, be attached to the expandable tubular framework of the inflow end of described inner support frame, described valve size indicator is positioned on described expandable tubular framework.

10. cardiac valve according to claim 9, wherein said expandable tubular framework comprises the pillar of a series of circumferential and axial, wherein upper strut is shaped as the peak portion and valley that have around its periphery, and described valve types indicator is incorporated to described framework along in described axial pillar below described upper strut.

11. cardiac valve according to claim 10, wherein said expandable tubular framework is metal, and is formed by valve types indicator described in cut in single laser cutting parameter and described framework.

12. 1 kinds of Cardiac valve prosthesiss, it comprises:

Inner support frame, it limits the flow orifice passed therethrough, described inner support frame limits by the separated multiple tip of Colaesce, described multiple tip is bending towards described inflow end, described support frame comprises the ring-type element at the inflow end place being arranged on described support frame, described ring-type element undulate thus there is peak portion and valley, wherein said peak portion corresponds to the described Colaesce of described support frame;

Multiple flexible leaflet, it is attached to described support frame and extends through described flow orifice and in described aperture, join the one-way flow guaranteeing to pass therethrough, each described tip along described support frame in described lobule and Colaesce attached at peripheral edge place; And

Indicator, it comprises at least one feature in ring-type element, described indicator there is the radiopacity at least partially different from the radiopacity of described ring-type element, described indicator instruction valve types and use outside imager visible.

13. cardiac valve according to claim 12, wherein said ring-type element be radiopaque at least partially, and described indicator comprises at least one opening, at least one opening described extends through at least one radiopaque part described of described ring-type element.

14. cardiac valve according to claim 12 or 13, wherein said ring-type element be radiopaque at least partially, and described indicator comprises at least one recess, at least one recess described is at least one radiopaque part described in described ring-type element.

15. according to claim 12 to the cardiac valve described in any one in 14, wherein said ring-type element comprises at least one expansible section, and at least one expansible section described is formed by making the free end at one of the described tip being arranged in described support frame most advanced and sophisticated place overlapping.

16. according to claim 12 to the cardiac valve described in any one in 15, and wherein indicator is arranged at least one place in the described peak portion of described ring-type element and described valley.

17. according to claim 12 to the cardiac valve described in any one in 16, the markd valve size of wherein said Cardiac valve prosthesis tool, and described valve types indicator comprises the digital value of the valve size equaling described labelling.

18. according to claim 12 to the cardiac valve described in any one in 17, the markd valve size of wherein said Cardiac valve prosthesis tool, and described valve types indicator comprises the non-numeric symbols of the valve size representing described labelling.

19. according to claim 12 to the cardiac valve described in any one in 18, wherein said Cardiac valve prosthesis comprises the expandable tubular framework of the inflow end being attached to described inner support frame further, and the second valve types indicator is positioned on described expandable tubular framework.

20. cardiac valve according to claim 19, wherein said expandable tubular framework comprises the pillar of a series of circumferential and axial, wherein upper strut is shaped as the peak portion and valley that have around its periphery, and described valve types indicator is incorporated to described framework along in described axial pillar below described upper strut.

21. 1 kinds for replacing the method for the artificial valve just needed, described method comprises:

Read the valve types indicator of the first artificial valve;

The second artificial valve is selected based on the described information read; And

Described second artificial valve is disposed in described first artificial valve.

22. methods according to claim 21, its be included in further dispose before described second artificial valve, same period or simultaneously, expand the diameter of described first artificial valve.

23. methods according to claim 21 or 22, it comprises further expands described second artificial valve after deployment.

24. methods according to any one in claim 21 to 23, wherein read described valve types indicator and comprise the size reading described first artificial valve.